While the present invention broadly applies to self-closing valves, it has particular application to self-sealing male and female luer valves used in medical applications.
Two primary prior art patents well disclose the need and opportunity for a male luer valve which is opened upon insertion into a female luer fitting. The first, U.S. Pat. No. 7,766,304 B2 issued to John C. Phillips (Phillips 304) Aug. 3, 2010 and titled, SELF-SEALING MALE LUER CONNECTOR WITH BIASED VALVE PLUG discloses a male luer connector for connection with a female luer connector. Phillips 304 further discloses a device comprising a tubular male body and a surrounding displaceable cuff. A valve plug is slidably disposed within the housing and formed to, in a first state, seal a communicating hole and, in a second state, be displaced to open the hole for fluid communication. Closure is biased to occur by an elastomeric coupling which communicates with the plug.
The second, U.S. Pat. No. 7,803,140 B2 issued to Thomas F. Fangrow, et al (Fangrow 140) Aug. 16, 2011 and titled, MEDICAL CONNECTOR discloses two primary designs for a male luer connector for connection with a female luer connector. The first design comprises a plugging component which is offset to open a valve for fluid flow. The second design discloses a slit valve which is opened for flow by insertion of a piercing part.
Such male valves provide barriers for infecting bacteria and debris, but perhaps more importantly provide a self-closing barrier and, thus, a closed system against inadvertent leakage, wherein product associated with such leakage might be a hazardous drug. It is important to note that such male valves should only be disposed in an open state while the valve is inserted into a complementary female fitting. At this date, all contemporary commercial male adapters for needleless connectors employ a linear displacement mechanism which removes a “plug” from a hole when the valve is inserted into a female luer fitting. Such mechanisms are commonly complex in structure and, therefore, result in an elevated component cost. Generally within the scope and meaning of this Application, the term male luer adapter shall be used as a reference for such male valves.
Further, male luer adapters such as those provided as examples, supra, are actuated to an open state by either a displacement of a plug within a hole or by a slit of a valve being parted by insertion of a piercing part. In the case of plug displacement, such is known to often result in a small droplet of liquid remaining resident at the exterior of the hole and plug site upon closure.
Slit valves are widely used and well understood in valve art to be most often made by slitting thin membrane material. Such valves are commonly used in medical practice, for example, in stop valves which are permissive to flow in only one direction. Such valves generally have no moving parts, except for membrane displacement to permit unidirectional flow.
Other examples of uses of slit valves in medical art is the application of slit valves in needleless medical connectors. Such connectors may be opened by linear displacement against a hollow probe which displaces lips of a slit to permit fluid flow, or may be released to open when displaced from a luer fitting.
Within the scope of this application, terms which are absolute, such as round, unreactive, closed, are understood to be permissive of manufacturing and physical limitations which, while functionally permitting a desired function, do not absolutely comply with definition of the term.